Decentralized trial sees increased adherence to heart medication
One of the first peer-reviewed assessments of a fully decentralized clinical trial (DCT) saw rapid recruitment (94% in 12 days), high engagement and that patients with low baseline increased their medication adherence. The study, known as DeTAP, led by the Stanford School of Medicine in collaboration with researchers at Bayer and Huma Therapeutics, highlights the huge potential for decentralized trials.
DeTAP was a 6-month, single-arm, 100% virtual study of 100 patients with a heart condition that causes an irregular and often abnormally fast heart rate, known as atrial fibrillation. Participants were aged >55 years old and on oral anticoagulation (OAC) medication. There were no in-person visits or measurements during the study. Participants enrolled and participated through an app and were sent remote blood pressure (BP) and electrocardiogram (ECG) sensors. The app collected the data and enabled reminders, surveys, educational content and video calls.
The trial was led by principal investigator Rajesh Dash, MD, PhD, associate professor of medicine at the Stanford School of Medicine.
Atrial fibrillation is the most common heart rhythm disturbance, causing more than 450,000 hospitalizations in the US each year1, and many patients are given medication to prevent a stroke. However, up to 30% of patients do not adhere to their medication2. Patient engagement may be key to improving adherence and in this DCT, which enabled more frequent contact, reminders and interactions, patients with low baseline adherence increased their medication adherence from 85 ± 16% to 96 ± 6% (P<0.01).
“At a time when digital health technologies are being pressed to provide more evidence3,” said Dr Mert Aral, Huma’s Chief Medical Officer, “our study shows that Huma’s DCT platform enables engaging and patient-centric research. Medication adherence is a major challenge in cardiovascular care so it is highly encouraging to see improvements, particularly for patients with poor baseline compliance, which will ultimately impact their prognosis. We are evaluating similar responses in the work we are doing in other therapeutic areas such as respiratory, musculoskeletal and neurodegenerative diseases.”
Traditional clinical trials can be slow, expensive and closed to any participants who are not near enough to a research site or do not have the means to make multiple visits. Recruitment is such an issue that up to 86% of clinical trials do not achieve their enrollment targets in the desired time4,5. In contrast, the DeTAP trial recruited 94 patients in just 12 days using social media (vs 6 in 28 days using traditional methods) with a waitlist of 300 more. Additionally, 86% of participants (69/80) expressed willingness to continue in a further 12-18-month-long trial.
Data collection is inevitably a key measure of success for a clinical trial. Patients typically have to travel to a clinic for a researcher to take their measurements. In DeTAP, participants used FDA-approved devices connected to Huma’s app and 99% of all ECG and BP measurements were completed, along with 91% of televisits and 85% of surveys.
Dr Arrash Yassaee, Global Clinical Director at Huma, said: “DCTs are the future of clinical trials, but there has been a dearth of evidence to show how well fully-decentralized trials work in the real-world, particularly for complex cases such as cardiac patients with atrial fibrillation. This study shows they can be safe, rapid, engaging and incredibly useful. Anyone wishing to run a fully-decentralized trial, particularly in the cardiovascular space, should take note.”
The research, Pandemic-proof recruitment and engagement in a fully decentralized trial in atrial fibrillation patients (DeTAP) is published in npj Digital Medicine.
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